{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"dosage_and_administration":["Directions • adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor • children under 12: consult a doctor • do not exceed recommended dose"],"effective_time":"20241007","how_supplied":["HOW SUPPLIED Product: 71335-1539 NDC: 71335-1539-0 18 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1539-1 30 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1539-2 100 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1539-3 60 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1539-4 120 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1539-5 90 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1539-6 180 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1539-7 10 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1539-8 28 CAPSULE, LIQUID FILLED in a BOTTLE NDC: 71335-1539-9 56 CAPSULE, LIQUID FILLED in a BOTTLE"],"id":"6a642587-b9c4-4ce0-929b-c2f3ef3f3776","inactive_ingredient":["Inactive ingredients FD&C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. Also contains D&C yellow #10 or FD&C yellow #6 (sunset yellow)."],"indications_and_usage":["Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Docusate Sodium 100mg Capsule Label Image"],"purpose":["Purpose Stool Softener Laxative"],"set_id":"b1d37f9e-ae8b-45c9-9c55-b094b2b0bce0","spl_product_data_elements":["Stool Softener Docusate Sodium FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SORBITOL WATER D&C YELLOW NO. 10 FD&C YELLOW NO. 6 MANNITOL DOCUSATE SODIUM DOCUSATE A92"],"storage_and_handling":["Other information • each softgel contains: sodium 5 mg. very low sodium • store at 15°C-25°C(59° F-77° F) • keep tightly closed • product from USA or Canada • Tamper Evident: Do not use if imprinted seal under cap is missing or broken."],"version":"2","warnings":["Warnings Ask a doctor before use if you • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}